The Effect and Safety of Plum-blossom Needle for Tourette Syndrome
1 other identifier
interventional
60
1 country
1
Brief Summary
To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 22, 2018
February 1, 2018
3.8 years
March 26, 2015
February 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of YGTSS score from baseline at the 12th week
the symptom scale used in this trial will be the Yale Global Tic Severity Scale. (YGTSS).
baseline, week 12
Secondary Outcomes (3)
change of YGTSS score from baseline at other point times
baseline, week 4, week 8, week 24.
CGI score
week 4, week 8, week 12, week 24.
change of quality of life from baseline
baseline, week 12, week 24.
Study Arms (2)
Plum-blossom needle group
EXPERIMENTALPatients randomized into this group will receive plum-blossom needle as treatment. DU 20, DU 16, GB 20, EX-HN5, BL 15, BL 18, BL 23 will be selected as acupoints. Each point will be tapped gently one by one by plum blossom needle until the skin get slightly redness. The treatments will be given two sessions per week, consistently for 12weeks (24 sessions in all).
HRT group
ACTIVE COMPARATORPatients randomized into this group will receive habit reversal training (HRT) as treatment. Habit reversal training will consist of the following 4 parts: (1) self-monitoring, (2) competing responses, (3) relaxation training and (4) contingency management. The training will be given weekly in the 12 weeks (totally 12 sessions) by a special rehabilitation therapist, first two sessions 1.5 h, and remaining sessions 1 h for each treatment.
Interventions
Plum-blossom needle is a method of shallow insertion with multiple needles. It is made of five or seven stainless steel needles arranged in a pattern like the shape of plum blossom, thus named as 'plum-blossom needle'. Plum-blossom needle treat diseases by tapping specific skin areas or acupoints according to different illness based on the theory of meridian.
HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management.
Eligibility Criteria
You may qualify if:
- Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-IV) for TS.
- Aged 7 to 18.
- Agree to participate in the trial and sign written informed consent by both guardians and subjects.
You may not qualify if:
- Having severe problem in heart, liver or kidney, or having hyperthyroidism.
- After evaluated by psychiatrists based on the Kiddie-Sads-Present and Lifetime Version, those who are associated with co-morbid conditions such as mental retardation, pervasive developmental disorder, schizophrenia, mania episode, bipolar disorder, anxiety and depression and specific learning disorder will be excluded.
- Tics symptoms caused by some drugs.
- Currently receiving any other form of pharmacological or non-pharmacological treatment for their Tourette syndrome.
- Patients with a history of psychotropic substance or alcohol use during the 3 months preceding screening.
- Patients with a history of nonresponsiveness to HRT or participating in another clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guang'an Men Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
Related Publications (1)
Yu J, Ye Y, Li S, Liu J, Zhai Y, Zhang M, Liu Z. The effectiveness and safety of plum-blossom needle therapy for Tourette syndrome: study protocol for a randomized controlled trial. Trials. 2015 Jul 29;16:320. doi: 10.1186/s13063-015-0873-0.
PMID: 26220439DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jinna Yu, Ph.D
Guang'an Men Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending doctor
Study Record Dates
First Submitted
March 26, 2015
First Posted
March 31, 2015
Study Start
January 1, 2015
Primary Completion
November 1, 2018
Study Completion
December 1, 2018
Last Updated
February 22, 2018
Record last verified: 2018-02